Founded in 1998, Kronberg-based inno-train Diagnostik GmbH develops and markets in-vitro diagnostics for transfusion and transplantation medicine, with a particular focus on immunohematology and high-resolution HLA and blood-group genotyping. The German company was an early provider of genetic blood-group typing and now serves customers in more than 50 countries, supported by its North American division and laboratory-focused training and support. Its products have been made under a DIN EN ISO 13485-certified quality system since 2003.
DIN EN ISO 13485:2016
CE-IVD
EU IVDR 2017/746
Good Manufacturing Practices (GMP)
Compliance program
GMP
Quality certification
WerfenFounded in Barcelona in 1966, Werfen is a family-owned diagnostics company focused on specialized diagnostics and patient care. The company develops and manufactures in vitro diagnostic systems and reagents, and its immunoassay technology center also produces antigens, antibodies, and immunoassays for the global IVD industry. Werfen reports a workforce of about 7,000 and operates directly in 30 countries, serving more than 100 territories through distributors.ORANGEBURG, NY
Maine Molecular Quality Controls, IncFounded in 2000 by clinical laboratory scientists Joan Gordon and Clark Rundell, Maine Molecular Quality Controls designs and manufactures molecular quality controls for inherited-disease and infectious-disease testing. Based in Saco, the company grew from Rundell’s patented method for stabilizing DNA constructs and Gordon’s manufacturing protocols, and it continues developing controls for emerging nucleic-acid technologies and custom in vitro diagnostic applications. Its quality system is certified to ISO 13485:2016 and supported by MDSAP accreditation.CINCINNATI, OH
QuidelOrtho CorporationQuidelOrtho Corporation develops and supplies in-vitro diagnostic testing products and laboratory systems, describing its work as transforming diagnostic data into actionable health information. Its offerings serve testing from the home and point of care through clinical laboratories and transfusion settings, and the company reports offering 550 assays across more than 140 countries and territories.ROCHESTER, NY
MACHEREY-NAGEL GmbH & Co. KGFounded in Düren in 1911 as a filter-paper manufacturer, MACHEREY-NAGEL now develops and makes analytical systems for chemical and biomolecular analysis. The fourth-generation family-owned company employs more than 700 people across three Düren sites and supplies customers in 150 countries, with solutions used in fields ranging from healthcare and biotechnology to environmental analysis. Its quality systems have been certified to international standards since 1996, including ISO 9001, ISO 13485 and ISO 50001.PENNSYLVANIA, PA